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QSYMIA Drug Profile

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When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in nineteen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qsymia

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QSYMIA

International Patents:	64
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	12
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Cleveland Clinic	Phase 4
University of Minnesota	Phase 2
AstraZeneca	Phase 3

See all QSYMIA clinical trials

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for QSYMIA

Tradename	Dosage	Ingredient	NDA	Submissiondate
QSYMIA	CAPSULE, EXTENDED RELEASE;ORAL	phentermine hydrochloride; topiramate	022580	2013-07-18

US Patents and Regulatory Information for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No			Y
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes			Y
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No			Y

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012

International Patents for QSYMIA

Country	Patent Number	Estimated Expiration
European Patent Office	2305228
Canada	2686633
European Patent Office	2305226
Hong Kong	1018743